BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLERIS II TISSUE PROCESSOR

    MDR report key: 6039627 · Received October 5, 2016

    Report

    Report Number
    6039627
    Event Type
    Injury
    Date Received
    October 5, 2016
    Date of Event
    September 10, 2016
    Report Date
    October 3, 2016
    Manufacturer
    LEICA BIOSYSTEMS
    Product Code
    IEO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    POLERIS TISSUE PROCESSOR FAILED RESULTING IN DEHYDRATED ONBOARDED TISSUE AND LOSS OF TISSUE VIABILITY FOR BREAST TISSUE BIOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653440 POLERIS II TISSUE PROCESSOR TISSUE PROCESSOR IEO LEICA BIOSYSTEMS NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention